NeuroOne Completes FDA Submission for OneRF Trigeminal Nerve Ablation System

NeuroOne Medical Technologies Corporation has filed its 510(k) submission to the U.S. Food and Drug Administration (FDA) for trigeminal nerve ablation earlier than previous guidance.

This submission leverages the company’s proprietary OneRF Ablation System RF generator platform for treating trigeminal neuralgia, a chronic pain condition affecting approximately 100,000 people in the United States.¹ The trigeminal nerve is the main facial sensory nerve associated with triggering excruciating pain for this condition. Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression (MCD), radiosurgery, or other percutaneous techniques.

The OneRF Trigeminal Nerve Ablation technology features a minimally invasive surgical procedure that uses radiofrequency (RF) energy to destroy abnormal tissue to relieve severe, chronic pain in the face. Differentiated features of this multi-contact probe are designed to use multi-point mapping of pain location, stimulation and ablation, all using the same electrode and with the safety of temperature-controlled ablation. These features are also present in the FDA 510(k)-cleared OneRF sEEG (brain) Ablation System. This system may allow for reduced procedural time, improved patient comfort and improved patient safety.

Previously published data have shown that RF ablation offers high initial pain relief rates (~95%) and long-term efficacy, especially with repeat treatments, while maintaining a low complication rate.^2,3 These characteristics make it a preferred option for patients who are not candidates for major surgery or want less invasive approaches.⁴

“Our OneRF ablation technology platform has already achieved successful commercialization and patient outcomes in lesioning nerve tissue for functional neurosurgical procedures, such as the treatment of epilepsy. Expanding into facial pain broadens the clinical impact of our technology and further validates the versatility and scalability of our platform,” NeuroOne Medical President/CEO Dave Rosa said. “If cleared by the FDA, we believe there is a potential to generate revenues from trigeminal nerve ablation in late calendar year 2025.”

NeuroOne Medical Technologies Corporation is developing and commercializing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries, and other related neurological disorders that may improve patient outcomes and reduce procedural costs. The company may also pursue applications for other areas such as depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence.

References
¹ American Association of Neurological Surgeons (AANS) – April 2024
² Kanpolat Y et al. Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgia: 25-year experience with 1,600 patients. Neurosurgery. 2001 Mar;48(3):524-32;. doi: 10.1097/00006123-200103000-00013.
³ Wang Z et al. Radiofrequency thermocoagulation for the treatment of trigeminal neuralgia. Exp Ther Med. 2022 Jan;23(1):17. doi: 10.3892/etm.2021.10939.
⁴ Emril DR, Ho KY. Treatment of trigeminal neuralgia: role of radiofrequency ablation. J Pain Res. 2010 Dec 12;3:249-54.doi: 10.2147/JPR.S14455.